NCT01105832

Brief Summary

40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4 weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual analoge scale (VAS). Two doctors, blinded to the treatment, will judge the callus formation and healing on the x-rays and guess the treatment. The DASH score and the pain score will be compared between the treatment groups. The investigators hypotheses are that callus formation and healing will be more pronounced and that patients have less pain and better function in the rhPTH 1-34 group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

3.8 years

First QC Date

April 13, 2010

Last Update Submit

December 9, 2014

Conditions

Humeral Fracture

Keywords

Teriparatidefracture healingproximal humeral fractures

Outcome Measures

Primary Outcomes (1)

  • Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment

    7 weeks

Secondary Outcomes (2)

  • Function

    7 weeks and 3 months

  • Pain

    7 weeks and 3 months

Study Arms (2)

Proximal humeral fracture - intervention

EXPERIMENTAL

20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo)

Drug: Teriparatide

Proximal humeral fracture

NO INTERVENTION

20 patients will receive standard treatment (physiotherapy)

Interventions

TeriparatideDRUG

Teriparatide (Forsteo) 20 micrograms daily during four weeks

Proximal humeral fracture - intervention

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • proximal humeral fracture
  • postmenopausal woman 50 years or older
  • non-surgical treatment

You may not qualify if:

  • dementia or psychiatric disorder
  • known malignancy \< 5 years prior to fracture
  • calcium above reference value
  • signs of liver disease
  • creatinine over ref. value
  • inflammatory joint disease
  • alcohol or drug abuse
  • oral corticosteroid medication
  • long-term NSAID-treatment (=\> 3 months prior to fracture)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lasarettet i Motala

Motala, Sweden

Location

Department of Orthopaedics

Norrköping, Sweden

Location

Related Publications (3)

  • Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.

    PMID: 19594305RESULT

  • Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946.

    PMID: 20367417RESULT

  • Johansson T. PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures. A randomized, controlled study of 40 patients. Acta Orthop. 2016 Feb;87(1):79-82. doi: 10.3109/17453674.2015.1073050. Epub 2015 Jul 15.

    PMID: 26179771DERIVED

MeSH Terms

Conditions

Humeral FracturesShoulder Fractures

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, BoneShoulder Injuries

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 19, 2010

Study Start

April 1, 2010

Primary Completion

February 1, 2014

Study Completion

September 1, 2014

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

SE(2)